Phase 2 Hearing Loss Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a confirmed diagnosis of testicular cancer and whose doctors have recommended a chemotherapy treatment that includes the drug cisplatin, based on current medical guidelines.
• Men between the ages of 18 and 45 years old.
• People whose planned cisplatin treatment involves a total dose of 300 mg/m² or more, given across three chemotherapy cycles.
• People whose ears look normal or have no medically significant findings when examined.
• People who have normal hearing in both ears at the start of the trial, based on standard hearing tests across a range of sound frequencies.
• People whose inner ear function (measured by a specific hearing test called DPOAEs) is normal in both ears at the start of the trial.
• People who have normal heart rate, blood pressure, heart tracing (ECG), and blood test results (including liver and kidney function) at the start of the trial.
• People who agree to use two forms of contraception — one of which must be a barrier method — for six months after the trial begins, along with their female partner(s).
• People who are able to understand all aspects of the trial and who can speak German at a level comparable to a native speaker, as assessed by the investigator.
• People who have read and signed a consent form showing they understand the trial and are willing to take part.

Who may not be able to join:

• People who have a known or suspected genetic condition that causes hearing loss (including a gene variant related to KCNQ4).
• People with a history of middle ear disease or surgery, outer ear infection, chronic middle ear infection, or a recent acute middle ear infection within the past three months.
• People who have had ear surgery in the past, other than minor procedures such as ear tube placement or simple eardrum repair.
• People with certain inner ear conditions, including Meniere's disease, immune-related hearing loss, fluctuating hearing loss, cochlear injury from pressure changes, radiation-related hearing loss, or significant scarring or thinning of the eardrum.
• People with hearing loss greater than 45 dB (averaged across two higher-pitched frequencies) in either ear.
• People who have had sudden hearing loss or a type of hearing loss caused by sound not reaching the inner ear properly, affecting certain frequencies in either ear.
• People whose hearing is noticeably different between their left and right ears beyond specified thresholds at certain frequencies.
• People who have taken or plan to take any other medications known to damage hearing (other than the planned cisplatin-based chemotherapy) before or during the trial.
• People who have previously received a significant dose of radiation to the inner ear area (more than 35 Gray).
• People with serious other health conditions, such as significant heart failure, severe lung disease, other active cancers, autoimmune or inflammatory conditions, advanced liver or kidney failure, or a primary complaint of ringing in the ears (tinnitus).
• People who plan to use medications, herbal products, or specific foods intended to treat hearing problems or tinnitus during the trial.
• People who have a known allergy or sensitivity to any ingredient in the trial medication or placebo.
• Men whose female partners are pregnant or planning to become pregnant within six months of the trial starting.
• People who have taken part in another clinical trial recently, or plan to do so during or shortly after this trial (confirm specific timeframes with the trial site).
• People who have an employment or dependent relationship with the trial site, the trial sponsor, or the investigators running the trial.

Important: Always verify eligibility with the trial site directly before applying.